NA 027
DIN Standards Committee Optics and Precision Mechanics
DIN EN ISO 10993-5 [CURRENT] referenced in following documents:
| Document number | Edition | Title |
|---|---|---|
| DIN EN IEC 80601-2-77 ; VDE 0750-2-77:2024-09 | 2024-09 | Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment (IEC 80601-2-77:2019 + AMD1:2023); German version EN IEC 80601-2-77:2021 + A1:2023 More |
| DIN EN ISO 10993-1 | 2021-05 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10); German version EN ISO 10993-1:2020 More |
| DIN EN ISO 10993-10 | 2023-04 | Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021); German version EN ISO 10993-10:2023 More |
| DIN EN ISO 10993-12 | 2021-08 | Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021); German version EN ISO 10993-12:2021 More |
| DIN EN ISO 11135 | 2020-04 | Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014 + Amd.1:2018); German version EN ISO 11135:2014 + A1:2019 More |
| DIN EN ISO 11334-4 | 2025-01 | Assistive products for walking, manipulated by one arm - Requirements and test methods - Part 4: Walking sticks with three or more legs (ISO 11334-4:2024); German version EN ISO 11334-4:2024 More |
| DIN EN ISO 11979-5 | 2021-05 | Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2020); German version EN ISO 11979-5:2020 More |
| DIN EN ISO 11979-6 | 2015-02 | Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing (ISO 11979-6:2014); German version EN ISO 11979-6:2014 More |
| DIN EN ISO 12417-1 | 2024-08 | Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2024); German version EN ISO 12417-1:2024 More |
| DIN EN ISO 14155 | 2021-05 | Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020); German version EN ISO 14155:2020 More |
